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Completed

NCT Number: NCT01283854

The Cycle Study: a Study of the Effectiveness of Cycling Exercise in Breaking the Cycle of Pregnancy Diabetes

Gestational diabetes mellitus (GDM) is one of the most common medical complications of pregnancy and has serious health implications for both the pregnant woman and her child. In particular, offspring of mothers with GDM have an increased prevalence of obesity, diabetes and metabolic syndrome, perpetuating serious health consequences in subsequent generations.

Although regular exercise offers numerous benefits for both the mother and her child, its effectiveness in preventing GDM remains to be established. It has been recently shown that regular supervised home-based exercise may attenuate the decline in glucose tolerance in obese pregnant women. This study aims to conduct a single-centred, multi-sited, single-blinded randomised controlled trial examining the effect of 14 weeks of supervised home-based exercise (commenced at 14 weeks gestation) on the recurrence and severity of GDM, along with other aspects of maternal and fetal wellbeing.

Eligible participants (n = 200) will be randomly allocated to an exercise intervention (n = 100) or a control group (n = 100). The exercise intervention will involve three 60-minute home-based, supervised exercise sessions each week. This type of program overcomes many of the barriers to exercise in this population including transportation, child care issues and embarrassment associated with exercising in a public venue. The investigators have already shown this program to be both feasible and warmly accepted by obese pregnant women.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

King Edward Memorial Hospital

Perth, Western Australia, 6008, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • women at 12-13 weeks gestation, with a history of gestational diabetes in a previous pregnancy.

Exclusion criteria

  • unable to participate in the supervised 14 week home-based exercise program
  • less than 18 years of age
  • unable to understand the implications of participation in the trial
  • women with a multiple pregnancy
  • women with pre-existing diabetes (type 1 or 2) or cardiac disease
  • women currently engaged in a structured exercise program

Treatment and study plan

Supervised home-based exercise

Behavioral

Each participant randomised to the exercise group will be required to participate in three 60-minute exercise sessions each week, starting at 14 weeks gestation, for a total of 14 weeks (i.e. to be completed by 28 weeks of gestation). All exercise sessions will be home-based and fully supervised by an experienced exercise physiologist. The exercise program will be implemented in accordance with the American College of Sports Medicine and the American College of Obstetrics and Gynecology guidelines. All sessions will be conducted on a stationary cycle ergometer.

Heart rate will be measured continuously during exercise to ensure that the exercise intensity is maintained as prescribed. In addition, blood pressure and rate of perceived exertion will be monitored at 10-min intervals. Perceived exertion will not be allowed to exceed a rating of 14 (i.e. "somewhat hard").

Primary outcomes

  1. Diagnosis of gestational diabetes mellitus

    Time frame: After the 14 week intervention period (28 weeks gestation)

Secondary outcomes

  1. Insulin sensitivity and glucose tolerance

    Time frame: Pre and post-intervention (14 and 28 weeks of gestation)

  2. Maternal aerobic fitness levels

    Time frame: Pre and post-intervention (14 and 28 weeks gestation)

  3. Maternal morphology (girths and skinfold measures)

    Time frame: Pre and post-intervention (14 and 28 weeks gestation)

  4. Maternal mental health

    Time frame: Pre and post-intervention (14 and 28 weeks gestation)

  5. Obstetric outcomes (rates of medical intervention during labour, birth weight, newborn anthropometrics and incidence of newborn hypoglycemia)

    Time frame: At time of delivery (approximately 40 weeks gestation)

Sponsors and collaborators

Lead sponsor

The University of Western Australia

Other

Collaborators

  • King Edward Memorial Hospital

Registry information

Official study title

Preventing Gestational Diabetes Mellitus Using a Home-based Supervised Exercise Program During Pregnancy

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jan 26, 2011
Registry last updated
Mar 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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